IKANOS: Breztri Maintenance Versus Any Non-Triple Inhaled Therapy After Hospitalization for a COPD Exacerbation in the US — IKANOS  

COPD Clinical Trial

Official title: IKANOS: A Prospective, Open-Label, Minimally Interventional Hybrid Study in the US Comparing Initiation of Breztri Maintenance Versus Any Non-Triple Inhaled Therapy at Discharge After a Hospitalization for a COPD Exacerbation

Status Withdrawn

Clinical Trial Summary

This study will evaluate whether prompt initiation and maintenance of Breztri (a triple therapy) following a severe COPD exacerbation hospitalization, is associated with a lower risk of all-cause readmissions at 90 days post-discharge, compared to receiving any non-triple inhaled therapy.

Clinical Trial Description

IKANOS is a prospective, open-label, minimally interventional Hybrid Study in the US Comparing Initiation of Breztri Maintenance versus Any Non-Triple Inhaled Therapy at Discharge after a Hospitalization for a COPD Exacerbation.

The interventional arm will be comprised of around 1000 patients for whom Breztri maintenance is prescribed, and the first dose is received prior to hospital discharge (the "index discharge") after a severe COPD exacerbation (the index admission).

At the end of the recruitment period of the interventional arm, the external comparator arm will be constructed from real-world data of patients contemporaneous with those in the interventional arm, from the same or similar integrated delivery network as the interventional arm and who are similar in key clinical and demographic characteristics.

Patients will be followed-up through their data and call center contact for up to 12 months. ;

Related Conditions & MeSH terms

• COPD

• NCT number: NCT05970263
• Study type: Interventional
• Source: AstraZeneca
• Status: Withdrawn
• Phase: Phase 4
• Start date: January 19, 2024
• Completion date: December 31, 2025